Peripheral Vascular Disease (PVD) is a clinical state caused by occlusion of arteries. It is therefore also known as Peripheral Arterial (Occlusive) Disease (PAD, PAOD). Physical examination that usually shows diminished or absent foot pulses, low Ankle-Brachial Pressure Index (ABI) (normal ABI≈1, pathological typically lower than 0.7). Imaging: Doppler ultrasonography, angiography and CT.
Treatment includes several available measures today: Conservative measures: smoking cessation, low-lipid diet, physical exercise, medications (for blood dilution, cholesterol chelation); Surgical revascularization: available options include: balloon angioplasty, for solitary lesions in large arteries, bypass grafting, for extended lesions and for fully or almost-fully occluded arteries, Plaque excision, Ulcers require additional local treatment, such as off-loading, debridement, dressings, Gangrene most often requires amputation.
Diabetic Foot: Prolonged Diabetes Mellitus (D.M.) affects the nervous and vascular systems in multiple ways that give rise to pathologies in the patient's foot including neuropathy and vascular disease. Ultimately, these pathologies, when combined with trauma to the skin, including even mild trauma caused by low pressure and friction of the shoe, will cause ulceration, possible infection of these ulcers, and gangrene. Failure to treat these often results in amputation. It is thought that worldwide around half of all foot ulcers and amputations in people with diabetes could be prevented.
Initial ulcer treatment is based on the following principles: Off-loading: bed rest, total contact cast, wheelchair, crutches, etc; Debridement (skin removal): sharp, enzymatic, etc; Moisture balance and dressings; Advanced wound management: Negative Pressure Wound Therapy (NPWT), growth factors, bioengineered tissue, etc.
Other therapeutic techniques include Negative pressure wound therapy (NPWT) and Vacuum Assisted Closure (V.A.C.).
Hyperbaric Oxygen Therapy: Intermittent Pneumatic Compression (I.P.C., ArtAssist®)—IPC is a technique that applies repeated compression of the lower limb in order to augment blood flow to these organs. Vibration—In 2007, Nakagami et al. found that applying vibrations at a fixed frequency of 47 Hz to the skin of the ear of mice induced vasodilation and an increase of perfusion.
Negative Pressure Wound Therapy (NPWT): NWPT is a method of treating tissue damage which involves applying a negative pressure over a wound, in order to encourage migration of epithelial and subcutaneous tissue for a time sufficient to close the wound.
Nevertheless, there is no system disclosed which can integrate effectively the broad combination of effective therapies required for the alleviation of diabetic lesions and ulcers on the lower limbs, or the consequences of venous insufficiency (CVI). U.S. Pat. No. 5,645,081 and U.S. Pat. No. 5,636,643 to ARGENTA provide Negative Wound Pressure Therapy type methods (NWTP) for treating tissue damage by applying negative pressures to the open wound constantly or cyclically.
Bio-Electric Stimulation Therapy (BEST) or micro current electro therapy (MET) documented beneficial effects at the cellular level including increase in ATP production by up to 500%, enhanced transmembrane transport, which include: amino acids, especially proline (important in connective tissue repair) and stimulation of fibroblasts. Some embodiments of the present invention disclose means for administering BEST sub protocols or MET sub protocols.
There is therefore a need to provide means and methods for promoting functional revascularisation and for treating diabetic foot ulcers and the complications thereof. Furthermore, there is a long felt and unmet need to provide integration of novel and current therapeutic protocols to the above stated aims.